Quality Assurance Expert
We are seeking a Quality Assurance Expert to drive supplier oversight, audits, and risk-based quality management across our global operations.
This role offers the opportunity to work as a QA subject matter expert across GMP and other GxP standards. The ideal candidate will have deep knowledge of international regulations and proven expertise in supplier qualification.
Responsibilities:
1. Act as global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
2. Lead and improve supplier qualification programme (risk, audits, monitoring).
3. Conduct audits, issue reports, track CAPAs, verify effectiveness.
4. Review/approve supplier documents: agreements, responses, changes, deviations.
5. Assess supplier quality systems vs global regs (EMA, OECD GLP, VICH GCP, ISO, HACCP).
6. Advise on procurement to ensure GxP compliance in supplier selection.
7. Support teams (R&D, QC, Regulatory, Procurement) in supplier investigations.
8. Deliver internal training on supplier qualification.
Requirements:
* Degree in Life Sciences, Pharmacy, Biotech, or related field.
* 7–10 years' QA experience in pharma, biologics, or vaccines.
* 5+ years hands-on in GxP supplier qualification & auditing (GMP + GLP/GLC/GDP).
* Bonus: experience with labs, contract manufacturing, or clinical service providers.
* Strong knowledge of EU GMP, FDA, OECD GLP, VICH GCP & ICH guidelines.
* Skilled in planning, conducting & reporting audits independently.
* Deep understanding of quality systems, agreements & risk-based supplier qualification.
* Experienced in investigations, CAPA management & change controls.